Insight Global is seeking an Investigator for a Pharmaceutical client in the greater Raleigh area. This is an onsite role, that requires heavy technical writing. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients. You will help us in investigation of our quality issues in manufacturing and quality laboratories. You will investigate deviations and out-of-specification results and atypical result investigations. Your problem solving skills will help to identify root cause and suggest appropriate corrective action plan. Your attention to detail will help us ensure that the reports are aligned to regulatory requirements and company policies.



You will:

- Perform impact risk assessment as well as assist in root cause determination and plans appropriate corrective action and preventative action.

- Ensure Quality Management System for the investigations department are followed and maintained.

- Conduct and write formal investigation reports with varying degrees of complexity with the assistance of plant personnel and oversight from Lead/Manager

- Frequently enters the production area wearing appropriate gowning as necessary, to collaborate with colleagues and gather information for each investigation.

- Prior investigation writing experience (with determination of product impact).

- Plans appropriate corrective action and preventative action (CAPA).

- Perform reviews and evaluate sensitive, confidential information and develops recommendations for use by the plant quality assurance department.

- Defining and recommending corrective and/or preventive actions identified through the investigation process.

- Facilitates strategy meetings.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.

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